Import Alert 68-08

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 68-08

Published Date: 03/18/2011

Type: DWPE

Import Alert Name:

"Animal Drug Imported For Use By Racetrack Veterinarians"

Reason for Alert:

The Center for Veterinary Medicine has received reports that the following drugs are being used illegally in race horses in this country:

1. Healon Injection or Hylartin V (Hyaluronic Acid or Sodium

Hyaluronate)

2. Arteparon (Glucosaminoglycan Polysulfuric Acid Ester)

3. Clenbuterol

4. Domosedan (Detomidine hydrochloride)

5. Circulon (Isoxsuprine hydrochloride)

We routinely receive complaints from state race track authorities about the illegal use of these drugs. Although we are not sure exactly how these drugs enter the country, we suspect they enter in small lots which escape detection. All of these drugs may legally enter when consigned to the holder of a valid INAD or approved NADA. Any product entering which does not conform to the requirements of an NADA/INAD must be denied entry. Following are the specifics of the appropriate NADA/INAD.

Pharmacia AB, Uppsala, Sweden, is the only source of hyaluronic acid provided for in the approved NADA. Pharmacia Inc., Piscataway, New Jersey is the sponsor named in the NADA. Any hyaluronic acid in import status not from Pharmacia and not going to Piscataway, New Jersey, should be denied entry.

According to our information, most of the illegal entries of hyaluronic acid originate in Italy. Pitman Moore also holds an INAD for hyaluronic acid (HYVISC) but they do not receive shipments from foreign sources.

Arteparon (glycosaminoglycan polysulfated ester) This is a human labeled product produced by Luitpold Werk, Munich, West Germany, being brought into the U.S. illegally for use in race horses. There is an approved NADA 136 383 for the same drug under the trade name Adequan manufactured by the same German firm. The U.S. sponsor is Dr. Lawrence Goldman, Jupiter, Florida.

Clenbuterol (INAD 2227)

Bohringer Ingelheim Ltd., in Germany is the only source of Clenbuterol provided for in the INAD. Philips Roxanne, Inc., 2621 North Belt Highway, St. Joseph, MO, is the sponsor named in the INAD. Clenbuterol should not be coming from any other source or going to any other consignee. Any Clenbuterol in import status not conforming to the above should be denied entry.

Domosedan (Detomidine Hydrochloride) (INAD 2956)

Domosedan is the trade name of the product approved in England and Finland. Wolfgang Jochle Associates, Inc., Denville, New Jersey, holds the INAD on behalf of the Farmos Group Ltd., Turku, Finland. Any detomidine hydrochloride not consigned to Wolfgang Jochle Associates should be detained.

Circulon (Isoxsuprine Hydrochloride) (INAD 2912)

Circulon is the trade name of the product approved in Australia. Ceva Labs, Overland Park, Kansas is the U.S. Sponsor of Circulon under this INAD. The legal drug is sent to Ceva Labs by Medical Research Pty. Ltd., Sydney, Australia. Any entries of Isoxsuprine hydrochloride not consigned to Ceva should be detained.

Guidance:

If any of these veterinary drugs are offered for import by any supplier other than the approved source and/or consigned to other than the approved sponsor, they should be detained.

Product Description:

Drugs 1. Healon Injection or Hylartin V (Hyaluronic Acid or Sodium

Hyaluronate)

2. Arteparon (Glucosaminoglycan Polysulfuric Acid Ester)

3. Clenbuterol

4. Domosedan (Detomidine hydrochloride)

5. Circulon (Isoxsuprine hydrochloride)

Charge:

"The article is adulterated within the meaning of section 801(a)(3) in that it appears to be a new animal drug within the meaning of section 201(w) which is adulterated within the meaning of 501(a)(5)."